NCT06520865

Brief Summary

Research in clinical neuroscience is founded on the conviction that a better understanding of tinnitus related changes of brain function will improve our ability to diagnose and treat tinnitus. Although considerable advances have been made in understanding the mechanisms of tinnitus, the clinical management of tinnitus remains largely based on a 'trial and error' approach. The identification and validation of a biomarker for tinnitus is thought to be the crucial step in the development of a personalized approach to the diagnosis and treatment of tinnitus. The overarching goal of this study is to incorporate advanced technologies to provide an objective, data-driven, personalized approach to the diagnosis of chronic tinnitus. This should lead to a clinically applicable tool that can be widely and easily used.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

March 24, 2026

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

July 22, 2024

Last Update Submit

March 19, 2026

Conditions

Tinnitus

Keywords

Tinnitus, Biomarker for Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Event-related potentials

    Event-related potentials of a 64-channel EEG

    4 hours

Study Arms (2)

Tinnitus cases/patients

Subjects that have a diagnosis of chronic and constant tinnitus (for at least 6 months based on history)

Other: Acoustic paradigms

Control group

Subjects that never experienced tinnitus (excluding short-term tinnitus, i.e. not tinnitus that persists over a longer period of time)

Other: Acoustic paradigms

Interventions

Acoustic paradigmsOTHER

Acoustic oddball Gap detection

Control groupTinnitus cases/patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with chronic tinnitus (for at least 6 months) and control subjects who have never had (except short-term) tinnitus.

You may qualify if:

  • (1) for tinnitus cases: a diagnosis of chronic and constant tinnitus (for at least 6 months based on history)
  • (2) for controls: never experienced tinnitus
  • (3) age 18 -70;
  • (4) ability to understand and consent to the research;
  • (5) ability to participate (hearing ability);
  • (6) MoCa Test ≥ 26;
  • (7) hyperacusis questionnaire score \< 27;

You may not qualify if:

  • (1) objective tinnitus; heartbeat-synchronous tinnitus as primary complaint;
  • (2) otosclerosis; acoustic neuroma or other relevant ear disorders with fluctuating hearing;
  • (3) acute ear nose and throat infections (acute otitis media, otitis externa, acute sinusitis);
  • (4) Meniere's disease or similar syndromes;
  • (5) vestibular migraine;
  • (6) serious internal, neurological or psychiatric conditions;
  • (7) epilepsy or other CNS disorders (brain tumor, encephalitis);
  • (8) clinically relevant drug, medication or alcohol abuse up to 12 weeks before study start;
  • (9) change in anti-depressants/drugs ≤ 2 weeks
  • (10) missing written informed consent
  • (11) severe hearing loss - inability to communicate properly in the course of the study;
  • (12) one deaf ear;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Illinois

Champaign, Illinois, 61820, United States

Location

University of Texas

Austin, Texas, 78712, United States

Location

Brai3n - Research center for Advanced, International, Innovative and Interdisciplinary Neuromodulation

Ghent, 9000, Belgium

Location

University of Tuebingen

Tübingen, Baden-Wurttemberg, 72074, Germany

Location

Center of Neuromodulation - Psychiatry und Psychotherapie der Universität Regensburg am Bezirksklinikum

Regensburg, Bavaria, 93053, Germany

Location

Trinity College Dublin

Dublin, Ireland

Location

OST - Eastern Switzerland University of Applied Sciences

Sankt Gallen, 9000, Switzerland

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sven Vanneste, Prof.

    Trinnitus College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 25, 2024

Study Start

August 1, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

March 24, 2026

Record last verified: 2025-12

Locations

DE(2)CH(1)US(2)BE(1)IE(1)